MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL TIBIA PLATE AXSOS 3 FOR RIGHT TIBIA 10 HOLE / L199MM; PLATE, FIXATION, BONE

Catalog Number	627340S
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported that: "an implant from our depot could not be placed at the (b)(6) hospital before its expiration date.".
Additional Manufacturer Narrative
Corrected fields: product available to stryker (d9), reporting contact (g1), clinical signs code grid, and health impact code grid (h6).The reported event could not be confirmed based on the documentation review during the investigation.The affected product was valid at the time of reported event.The incident was reported on (b)(6) 2024 and the product was supposed to get expired on (b)(6) 2025.There was a request raised by the hospital to replace the implant prior to its expiration which is confirmed during communications.This could be due to non-usage of the device during its validity.Therefore, the root cause of the event was attributed to a user preference related issue because the user did not use the device during the time period of its validity and preferred to get it exchanged before the expiration of the device.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Labeling and design review was not deemed necessary for the reported event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported that: "an implant from our depot could not be placed at the (b)(6) hospital before its expiration date.".

• Brand Name: PROXIMAL LATERAL TIBIA PLATE AXSOS 3 FOR RIGHT TIBIA 10 HOLE / L199MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21164526
• Report Number: 0008031020-2025-00111
• Device Sequence Number: 21201132
• Product Code: HRS
• UDI-Device Identifier: 04546540685629
• UDI-Public: (01)04546540685629(17)250131(10)D61676
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: 627340S
• Device Lot Number: D61676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown